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The goal of this single-arm study is to learn if a dog adoption and training program can treat, prevent in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Intervention | Experimental | Within-subjects design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dog training | Other | Eight, one-hour professional dog training sessions over 8-10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-reported posttraumatic stress disorder (PTSD) symptoms from baseline to 4 weeks post-intervention | Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report measure of PTSD symptoms with scores ranging from 0 to 80. | From enrollment to 4 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression symptom severity from baseline to 4 weeks post-intervention | Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depressive symptoms with scores ranging from 0 to 27. | From enrollment to 4 weeks post-intervention |
| Change in anxiety symptom severity from baseline to 4 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in alcohol demand for participants who answer "yes" to alcohol consumption in the AUDIT measure from baseline to 4 weeks post-intervention | Alcohol Purchase Task is a tool to measure alcohol demand by asking individuals how many drinks they would consume at prices ranging from free to high, using behavioral economic indices for scoring. | From enrollment to 4 weeks post-intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beth A Pratt, PhD | Contact | 561-297-4912 | bpratt4@health.fau.edu |
| Name | Affiliation | Role |
|---|---|---|
| Beth A Pratt, PhD | Florida Atlantic University | Principal Investigator |
| Cheryl A Krause-Parello, PhD | Florida Atlantic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Atlantic University | Recruiting | Boca Raton | Florida | 33431 | United States |
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Generalized Anxiety Disorder-7 (GAD-7) is a is a 7-item self-report measure of anxiety symptoms with scores ranging from 0 to 21. |
| From enrollment to 4 weeks post-intervention |
| Change in perceived stress severity from baseline to 4 weeks post-intervention | Perceived Stress Scale-10 (PSS-10) is a 10-item self-report measure of perceived stress symptoms with scores ranging from 0 to 40. | From enrollment to 4 weeks post-intervention |
| Change in sleep disturbance from baseline to 4 weeks post-intervention | Patient-Reported Outcomes Measurement Information System Sleep 8b (PROMIS Sleep 8b) is an 8-item self-report measure of sleep quality over the past 7 days with raw scores ranging from 8 to 40 and standardized T scores ranging from 28.9 to 76.5. | From enrollment to 4 weeks post-intervention |
| Change in loneliness from baseline to 4 weeks post-intervention | Revised UCLA Loneliness Scale is a 20-item self-report measure of loneliness with scores ranging from 20 to 80. | From enrollment to 4 weeks post-intervention |
| Change in alcohol use from baseline to 4 weeks post-intervention | Alcohol Use Disorder Identification Test (AUDIT) is a 10-item self-report measure of alcohol use with scores ranging from 0 to 40. | From enrollment to 4 weeks post-intervention |
| Change in cannabis use from baseline to 4 weeks post-intervention | Cannabis Use Disorder Identification Test (CUDIT) is an 8-item self-report measure of cannabis use with scores ranging from 0 to 32. | From enrollment to 4 weeks post-intervention |
| Change in salivary oxytocin levels from baseline to 4 weeks post-intervention | Oxytocin is a neurotransmitter that plays a role in determining social behavior. Salivary oxytocin levels range from 6.4-1000 pg/mL. | From enrollment to 4 weeks post-intervention |
| Change in Interleukin-1 beta (IL-1β) from baseline to 4 weeks post-intervention | IL-1β is a pro-inflammatory cytokine found to be higher in individuals with PTSD compared to healthy controls. IL-1β is measured via capillary blood obtained via fingerstick. | From enrollment to 4 weeks post-intervention |
| Change in Interleukin-6 (IL-6) from baseline to 4 weeks post-intervention | IL-6 is a pro-inflammatory cytokine found to be higher in individuals with PTSD compared to healthy controls. IL-6 is measured via capillary blood obtained via fingerstick. | From enrollment to 4 weeks post-intervention |
| Change in tumor necrosis factor-alpha (TNF-alpha) from baseline to 4 weeks post-intervention | TNF-alpha is a pro-inflammatory cytokine found to be higher in individuals with PTSD compared to healthy controls. TNF-alpha is measured via capillary blood obtained via fingerstick. | From enrollment to 4 weeks post-intervention |
| Change in cannabis demand for participants who answer "yes" to cannabis use from baseline to 4 weeks post-intervention | Cannabis Purchase Task is a tool to measure cannabis demand by assessing how much an individual purchases at increasing prices. | From enrollment to 4 weeks post-intervention |
| Change in Magnetic Resonance Imaging (MRI) biomarkers from baseline to 4 weeks post-intervention | Optional participation in an MRI to detect changes in the structure and resting-state function of specific brain regions (anterior cingulate, amygdala, hippocampus, and insula) | Pre-intervention and 4 weeks post-intervention |